NEUROBALANCE Training to Improve Postural Control in Individuals With Traumatic Brain Injury

NCT ID: NCT06584591

Last Updated: 2025-08-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-01
• Study Completion Date: 2027-12-31

Brief Summary

Our proposed study, "NEUROBALANCE," aims to evaluate the effectiveness of a combined intervention involving robotic balance training and noninvasive brain stimulation in improving balance functions in individuals with chronic traumatic brain injury (TBI). The study will recruit 45 participants who have had a TBI for over six months and experience persistent balance deficits. Participants will be randomized into three groups: (1) robotic balance training with active brain stimulation, (2) robotic balance training with sham brain stimulation, and (3) standard-of-care rehabilitation.

The study will involve 12 training sessions over four weeks, with assessments conducted at baseline, post-training, and two months post-training to evaluate balance recovery and retention. The primary focus is understanding how this intervention affects brain and muscle activity during balance tasks and how these changes translate into functional improvements in clinical outcome measures of balance function. Additionally, participant feedback on brain stimulation and exercise engagement will be collected to inform future studies.

This research is particularly relevant to military service members, as TBI and balance impairments are common among this population. The findings may guide the development of personalized training protocols and contribute to broader rehabilitation strategies.

Detailed Description

Background: Traumatic Brain Injury (TBI) is one of the severe health conditions with debilitating consequences, affecting more than 2.5 million individuals in the US alone. Balance dysfunction is one of the most disabling outcomes of TBI, affecting roughly half of those who have TBI even after ten years have passed after their accident, and further, it increases the risk of falls due to poor postural control. The current challenges are that there are currently no well-established rehabilitation treatments that have been shown to have long-term retention of balance recovery in TBI survivors with chronic balance complaints. Therefore, we need novel therapeutic strategies using rehabilitation engineering that can target sensorimotor integration and improved proprioceptive control to improve balance function, thereby alleviating the long-term burden on TBI survivors and their caregivers.

Hypothesis and Rationale: We hypothesize that the balance and postural control recovery requires a multimodal strategy, and we propose robotic balance training (RBT) using the Hunova platform (Movendo Technology, Italy), as it has an advantage of supporting dynamic balance in not only sagittal plane but also transverse plane (mediolateral and anterior-posterior directions), and allows for core stability and trunk control with its unique seated balance exercises. In addition, we hypothesize that by using high-definition transcranial direct current stimulation (HD-tDCS) as an adjuvant to RBT, HD-tDCS will facilitate top-down neuromuscular control of balance through corticospinal circuits, whereas the robotic platform will enable bottom-up feedback of response to platform perturbations. Overall, we anticipate that the combined intervention will improve reactive and anticipatory postural control, position sense, and proprioceptive control, gain lower-limb strength, increase ankle range of motion, and stimulate attention through game-like exercises.

Study Design: We propose a single-center, investigator-blinded, randomized, sham-controlled triple-arm parallel-group, superiority trial study. Forty-five adult individuals with chronic TBI with complaints of balance dysfunction (injury onset > 6 months before screening) will be randomized into one of the three groups: (1) Real HD-tDCS + RBT, (2) Sham HD-tDCS + RBT, and (3) Control group receiving dose-matched standard of care rehabilitation treatment. All participants will undergo 12 sessions (3 days × 4 weeks) of intervention. A total of 3 assessment visits (before training, immediately after 4-week training, and 2-months after the last training visit) will be conducted to evaluate the functional recovery and neurophysiological changes due to intervention.

Specific Aim-1: To determine whether there is an overall treatment effect of targeted neuromodulation combined with robotic balance training on balance outcomes immediately after 4-week training function in people with TBI. The change in Berg Balance Scale score from baseline to 4-week post-training will be the primary outcome measure. The secondary outcome measures of balance recovery will be the changes in Mini BESTest, Functional Gait Assessment, and Trunk Impairment Scale scores from baseline to 4-week post-training. We hypothesize that the Real HD-tDCS + RBT will show the largest improvement in the balance outcomes.

Secondary Aim-2: To characterize the top-down and bottom-up neurophysiological mechanisms of balance control due to neuromodulation-enhanced robotic training. We will measure the neurophysiological outcomes of EEG and EMG activity, and posturography outcomes of body sway during platform perturbation task at baseline, 4-week post-training, and 2-month follow-up. Specifically, the intervention-induced changes in the cortical reactivity amplitude, muscle coactivation, and center of displacement will be compared across groups.

Secondary Aim-3: To study the association between the intervention-related changes in the balance function endpoints and graph-theoretic measures of cortical functional connectivity. We will use a multivariate statistical approach-partial least squares correlation-to identify a latent component that characterizes the correlation between the 4-week intervention-related changes in balance outcome measures and EEG corticocortical functional connectivity features measured during platform perturbation task.

Conditions

Traumatic Brain Injury; TBI; Diffuse Axonal Brain Injury; Brain Injuries, Traumatic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

RBT + Active HD-tDCS Group

Participants will engage in balance and postural control training on a robotic balance platform called Hunova (Movendo, Italy). Before balance training, the current intensity of 2 mA will be delivered to the leg motor area identified using neuronavigated transcranial magnetic stimulation, and the stimulation will be turned ON for 20 minutes.

Group Type: EXPERIMENTAL

Combined (Robotic balance training and high-definition transcranial direct current stimulation)

Intervention Type: DEVICE

The robotic platform will train the participants to maintain dynamic balance in the sagittal and the transverse planes (mediolateral and anterior-posterior directions) and engage in core stability and trunk control with seated balance exercises. In addition, high-definition transcranial direct current stimulation (HD-tDCS) will be used as an adjuvant to robotic balance training by priming the corticospinal circuits.

RBT + Sham HD-tDCS Group

Participants will engage in balance and postural control training on a robotic balance platform called Hunova (Movendo, Italy). Before balance training, the current intensity of 2 mA will be delivered to the leg motor area identified using neuronavigated transcranial magnetic stimulation, and the stimulation will be turned ON transiently for 30 s, to provide a sensation of stimulation.

Group Type: SHAM_COMPARATOR

Combined (Robotic balance training and high-definition transcranial direct current stimulation)

Intervention Type: DEVICE

The robotic platform will train the participants to maintain dynamic balance in the sagittal and the transverse planes (mediolateral and anterior-posterior directions) and engage in core stability and trunk control with seated balance exercises. In addition, high-definition transcranial direct current stimulation (HD-tDCS) will be used as an adjuvant to robotic balance training by priming the corticospinal circuits.

SOC Control Group

The SOC control group participants will perform conventional physical therapy exercises delivered by a trained PT.

Group Type: OTHER

Standard of Care Balance Training

Intervention Type: OTHER

Participants in this group will receive a standard-of-care balance training administered by the Physical therapist.

Interventions

Combined (Robotic balance training and high-definition transcranial direct current stimulation)

The robotic platform will train the participants to maintain dynamic balance in the sagittal and the transverse planes (mediolateral and anterior-posterior directions) and engage in core stability and trunk control with seated balance exercises. In addition, high-definition transcranial direct current stimulation (HD-tDCS) will be used as an adjuvant to robotic balance training by priming the corticospinal circuits.

Intervention Type: DEVICE

Standard of Care Balance Training

Participants in this group will receive a standard-of-care balance training administered by the Physical therapist.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Aged between 18-75 years

2. Diagnosed with a non-penetrating TBI at least six months before the screening.

3. Have complaints of impaired balance and poor postural control determined by a BBS score of ≤50.

4. Ability to stand upright with or without support for at least 20 seconds

5. Ability to walk with or without a walking aid for at least ten meters

6. Not planning to change medication in the next four months

7. Minimum Cognitive Ability to understand the verbal instructions and comply with the study procedures, as determined by the University of California, San Diego, Brief Assessment of Capacity to Consent Instrument (UBACC).

Exclusion Criteria

1. Currently undergoing any regular physical therapy program or research studies focusing on balance functions.

2. Having a stroke or a penetrating TBI.

3. Affected by the peripheral nerve injury, neuromuscular conditions, or orthopedic issues of lower limbs before TBI, or have any persistent pain or difficulty maintaining blood pressure while upright.

4. Have a scalp or skin condition (e.g., psoriasis or eczema) on the scalp near the stimulation site.

5. Severe visual impairment (e.g., spatial neglect) or hearing problems may affect study compliance.

6. Any other neurological injury or psychiatric conditions (e.g., severe anxiety or schizophrenia, etc.)

7. Not being pregnant or thinking of becoming pregnant during the study period.

8. Diagnosed with alcohol or substance abuse in the last three years.

9. Contraindications to TMS, including the presence of metallic implants in the head and history of seizures or medication-resistant epilepsy.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

United States Department of Defense

FED

Sponsor Role: collaborator

Kessler Foundation

OTHER

Sponsor Role: lead

Responsible Party

Vikram Shenoy Handiru

Research Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Vikram Shenoy Handiru, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Kessler Foundation

Locations

Kessler Foundation

West Orange, New Jersey, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Vikram Shenoy Handiru, Ph.D.

Role: CONTACT

vshenoy@kesslerfoundation.org

9733243578

Kathleen Goworek, B.S.

Role: CONTACT

kgoworek@kesslerfoundation.org

Facility Contacts

Vikram Shenoy Handiru, Ph.D.

Role: primary

Other Identifiers

R-1261-24

Identifier Type: -

Identifier Source: org_study_id